Method, System and Apparatus for Dispensing Drugs

ABSTRACT

A method, system and apparatus is provided for dispensing drugs quickly, conveniently, securely, and accurately and at relatively less cost than traditional pharmacy-based dispensing systems. A script for a drug prescribed to a user is generated comprising a human readable description of the drug and the user or a machine readable description of the drug and the user. The script is provided to a robotic prescription dispensary operable to recognize either the human readable description or the machine readable description, and validate and dispense the drug accordingly. The robotic prescription dispensary includes a user interface, a teleconferencing or videoconferencing means enabling communication between the user and a human validation agent, and a scanning means for capturing an image of the script. A method for managing inventory and distribution of drugs is also provided.

This application is a divisional of U.S. application Ser. No. 12/305,759filed on Dec. 19, 2008, based on PCT Application No. PCT/CA2007/001220.

PRIORITY

This application claims the benefit of U.S. Provisional PatentApplication No. 60/819,622, filed 11 Jul. 2006.

FIELD OF THE INVENTION

The present invention relates to method, system and apparatus fordispensing drugs.

BACKGROUND OF THE INVENTION

The traditional means of dispensing drug involves a doctor meeting witha patient and prescribing drugs or drugs based on a particulardiagnosis. A prescription is then hand written or printed, and generallymust be signed. The doctor generally updates the patient's paper file,and the patient takes their prescription to a pharmacy to be filled.

This traditional system of dispensing drug is considered relativelyslow, inefficient, inconvenient, and various security or accuracyproblems can arise. For example, a pharmacy can encounter a problem witha prescription because of the illegibility of the handwriting, whichrequires a call back to the doctor for clarification. There is also apotential problem where the wrong prescription is filled if the pharmacydoes not do the call back to clarify a prescription. Further, potentialadverse drug interactions are dependant on the doctor or pharmacistmanually researching or knowing the interactions in order to recognizethe possible issues and alter a prescription on that basis. Becausedrugs have a finite lifespan, there are also a number of inventorymanagement issues which have yet to be addressed by current drugdispensing methodologies.

In view of these and other problems, a novel method, system andapparatus for dispensing drugs is desirable.

SUMMARY OF THE INVENTION

The present invention provides a method, system and apparatus fordispensing drugs quickly, conveniently, securely, accurately and at lessrelative cost than traditional pharmacy-based dispensing systems.

In one aspect of the present invention, a method, system and apparatusfor dispensing drugs enables doctors to prescribe drugs to patients bygenerating a script. The script is a unique identifier comprising one ormore data elements. The unique script in turn allows a patient to filltheir prescription via a robotic prescription dispenser, referred to asa “dispensary”. The dispensary is operable to recognize the one or moredata elements, and the drugs are dispensed on that basis.

The script can comprise two data components, for example: (a) humanreadable descriptions for a pharmacist to dispense the prescribed drugs;and (b) machine readable descriptions for the dispensary to dispense theprescribed drugs. The two components allow the patient choice whenfilling their prescription.

According to another aspect of the present invention, the dispensary canbe located in the doctor's office or clinic and can be electronicallylinked to a computer used by the doctor, either directly or via aserver. As a result, the present invention allows a patient to obtainprescribed drugs without having to attend a pharmacy or drug store.

According to another aspect of the present invention, the dispensary canbe linked to a pharmacist via a communication medium such as amultimedia videoconferencing technology. The pharmacist can monitor thedispensary and approve each prescription.

According to an embodiment of the present invention, a system fordispensing drugs comprises: a server computer; a database of patientinformation linked to the server computer; a computer input means linkedto a server computer, wherein the computer input means is operable togenerate a script for a drug prescribed to a user, wherein the scriptcomprises a plurality of data elements, the plurality of data elementsincluding: a human readable description of the drug and the user; or amachine readable description of the drug and the user; and a roboticprescription dispensary operable to recognize either the human readabledescription or the machine readable description of the drug and theuser, wherein the robotic prescription dispensary is linked to theserver computer enabling cross-referencing between the machine readabledescription and the patient information to validate dispensing the drugto the user on the basis of the machine readable description, andwherein the robotic prescription dispensary comprises: a user interface;a teleconferencing or videoconferencing means enabling communicationbetween the user and a human validation agent to validate dispensing thedrug to the user on the basis of the human readable description; and ascanning means for capturing an image of the script so that it can beviewed by the human validation agent.

For example, the doctor uses the computer input means (for example, atablet computer) which is linked to the server to input the appropriateprescription information, or accept certain prescription information asbeing applicable in the particular case. The doctor enters theprescription into the tablet computer which displays the patientinformation, e.g., drug history, insurance coverage, etc. To the extentthat the present invention enables access to personal information, thesystem incorporates known technology for maintaining privacy. In aparticular embodiment of the present invention, a printer module isprovided to print the script as a paper print-out comprising text and amachine readable bar code or the like. Alternatively, the prescriptioninformation can be loaded on a smart card or the like.

In a particular aspect of the present invention, the system includes oris linked to a database for storing, compiling and enabling retrieval ofrelevant patient information, for example, the patient's personalinformation such as name and address, as well as health-relevantinformation such as diagnostic history and drug history. Access to thedatabase may be provided to both the doctor and to the dispensary viathe server, via a secure connection, or via a link between the systemand a clinic's existing clinic management system or patient database.

In a particular aspect of the method of the present invention, a patientseeking to fill a prescription provides the script to the dispensary,the dispensary having a user interface. At each step, the user interfaceprovides detailed and clear instructions to guide the patient. Anauthentication means confirms the identity of the patient, for example,by prompting for a personal identification number or by biometric meansor by associating certain questions to answers provided by the patientthat identify the patient to the robotic prescription dispenser. Oncethe patient is recognized, the dispensary will prompt the patient forthe script.

The dispensary is operable to process the script, and optionallyverifies information with the server and the database. In a particularembodiment, the dispensary interfaces with the server, or with anadjudication server, to adjudicate any insurance claim and to determinethe amount payable by the patient. The patient either accepts or rejectsthe transaction. If the transaction is accepted, the dispensary willinterface with the server, or with a transaction server, to transact apayment, for example, by prompting the patient for credit cardinformation. The dispensary is operable to print prescription labels andreceipts. The dispensary confirms that the medication is correct anddrops it into a dispensing area within the dispensary while retainingthe script in a lock box. The dispensary verifies that the medicationhas been retrieved. The robotic prescription dispenser optionally printsor provides educational materials to the patient relevant to theparticular prescription drugs being dispensed.

According to yet another aspect of the present invention, a method formanaging the distribution of a drug is provided comprising receiving thedrug, retrieving or defining standard operating procedures applicable tothe drug, applying the standard operating procedures to the drug,recording drug attributes, applying RFID as means for tracking the drug,and placing the drug into distribution. Preferably, radio frequencyidentification (“RFID”) device technology is implemented to track andcontrol the dispensing of drug throughout the supply chain, includinginside the robotic prescription dispensary. Inventory management canalso be achieved both for the robotic prescription dispensary and one ormore warehouses where the drugs are stockpiled prior to being stockedinto a robotic prescription dispensary.

BRIEF DESCRIPTION OF THE DRAWINGS

A detailed description of one or more embodiments is provided herein byway of example only and with reference to the following drawings, inwhich:

FIG. 1 is a flowchart illustrating steps for generating a prescription;

FIG. 2 illustrates an example of a script;

FIG. 3 is a system diagram according to an embodiment of an aspect ofthe present invention;

FIG. 4 is a further system diagram according to an embodiment of anaspect of the present invention;

FIG. 5 illustrates a schematic of a robotic prescription dispensary;

FIG. 6 is a flowchart illustrating steps for having a prescriptionfilled;

FIG. 7 is a flowchart illustrating steps for a method of drugdistribution; and

FIG. 8 illustrates an example of a drug pedigree certificate inaccordance with an aspect of the present invention.

In the drawings, one or more embodiments of the present invention areillustrated by way of example. It is to be expressly understood that thedescription and drawings are only for the purpose of illustration and asan aid to understanding, and are not intended as a definition of thelimits of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The term PharmaTrust™ as used herein denotes systems, methods andapparatuses in accordance with one or more embodiments of the presentinvention.

The present invention provides a method, system and apparatus fordispensing drugs quickly, conveniently, securely, accurately and at lessrelative cost than traditional pharmacy-based dispensing systems.

In one aspect, the present invention is a method for dispensing drugscomprising generating a script for a drug prescribed to a user, thescript comprising a plurality of data elements, wherein the plurality ofdata elements include (i) a human readable description of the drug andthe user; or (ii) a machine readable description of the drug and theuser, providing the script to a robotic prescription dispensary operableto recognize either the human readable description or the machinereadable description, authorizing dispensing the drug to the user basedon a validation means, and dispensing the drug to the user with therobotic prescription dispensary. The two components of the script andthe ability of the dispensary to recognize regular prescriptions andmachine readable prescription compatible with the dispensary allow thepatient choice when filling their prescription.

According to another aspect of the present invention, the roboticprescription dispensary is linked to the server computer enablingcross-referencing between the machine readable description and thepatient information to validate dispensing the drug to the user on thebasis of the machine readable description. The robotic prescriptiondispensary may also comprise a user interface, a teleconferencing orvideoconferencing means enabling communication between the user and ahuman validation agent, and a scanning means for capturing an image ofthe script so that it can be viewed by the human validation agent, e.g.,a licensed pharmacist. The pharmacist can monitor the dispensary andapprove each prescription, if desired.

According to another aspect of the present invention, the roboticprescription dispensary can be located in the doctor's office or clinicand can be electronically linked to a computer input means used by adoctor prescribing a drug to a patient, for example, either directly orvia a server. As a result, the present invention can allow a patient toobtain prescribed drugs without having to attend a pharmacy or drugstore.

In one embodiment, a system in accordance with the present inventioncomprises a server computer, a database of patient information linked tothe server computer, a computer input means linked to the servercomputer operable to generate the script for a drug prescribed to auser, and the robotic prescription dispensary operable to recognizeeither a human readable description or a machine readable description inthe script, enabling cross-referencing between the machine readabledescription and the patient information to validate dispensing the drugto the user on the basis of the machine readable description, therobotic prescription dispensary including a user interface,teleconferencing or videoconferencing means enabling communicationbetween the user and a human validation agent to validate dispensing thedrug to the user on the basis of the human readable description, and ascanning means for capturing an image of the script so that it can beviewed by the human validation agent.

A doctor in a clinic can use the computer input means (for example, atablet computer) linked to the server to input the appropriateprescription information, or accept certain prescription informationfrom the database as being applicable in the particular case for aparticular patient. The doctor can enter the prescription into thetablet computer which displays the patient information, e.g., drughistory, insurance coverage, etc. A printer module can print the scriptas a paper print-out.

The server computer and database enable storing, compiling and retrievalof relevant patient information, for example, the patient's personalinformation such as name and address, as well as health-relevantinformation such as diagnostic history and drug history. Access to thedatabase can be provided to both the doctor and the robotic prescriptiondispensary via the server, via a secure connection, or via a linkbetween the system and a clinic's existing clinic management system orpatient database.

According to another aspect of the present invention, the user interfaceof the robotic prescription dispensary provides detailed and clearinstructions to guide the user. An authentication means confirms theidentity of the patient, for example, by prompting for a personalidentification number or by biometric means or by associating certainquestions to answers provided by the patient that identify the patientto the robotic prescription dispensary, and cross-referencing thisinformation with the patient information stored on the database. Oncethe patient is recognized, the robotic prescription dispensary willprompt the user for a script. The robotic prescription dispensaryprocesses the script either by a human validation agent, e.g., alicensed pharmacist, reviewing the human readable description of thedrug and/or processing the machine readable description, e.g., abarcode, if applicable. This information can be verified with the serverand the database. The robotic prescription dispensary may also interfacewith the server to adjudicate an insurance claim and determine theamount payable by the patient. The patient either accepts or rejects thetransaction. If the transaction is accepted, the robotic prescriptiondispensary will interface with the server to transact a payment, forexample, by prompting the patient for credit card information.Prescription labels and receipts are printed. The robotic prescriptiondispensary preferably confirms that the drug is correct and drops itinto a dispensing area while retaining the script in a lock box. Therobotic prescription dispensary verifies that the drug has beenretrieved. The robotic prescription dispensary optionally also prints orprovides educational materials to the patient relevant to the particularprescription drugs being dispensed.

With reference to FIG. 1, the following describes an example of theprocess of prescribing a drug using a prescribing application residenton a computer input means. Elements of this process apply to the use ofother applications that leverage the prescription technology and processlogic in accordance with the present invention.

The doctor examines the patient, and determines the drug to beprescribed. The doctor logs into the prescribing application, which canbe a custom developed software application or a modified version of anexisting prescribing application. User authentication can be performedvia user name and password, biometric authentication, smart card, or anyother appropriate means. The doctor's profile includes information andpreferences that can impact the behaviour of the prescribing system(favourite drug lists, notification preferences, etc.).

Once the create prescription screen is displayed, the doctor selects apatient from the dropdown list. This list displays all patientscurrently checked in to the clinic, and also has the capability tosearch the clinic's entire patient list or add a new patient. Patientdemographic and historical information are retrieved with the patientprofile (e.g., contact information, benefits coverage, prescriptionhistory, etc.). Patient information can be drawn in real time fromeither an existing clinic management system in use at the clinic, apatient database or other such system in use by the clinic or thecentral system database. Links to external systems are generallyfacilitated by standard data-sharing methods such as direct databaseaccess or Application Programming Interface (API) integration.

Once the patient has been selected, the doctor selects a drug toprescribe. The drug dropdown list can be displayed in categories tosimplify drug selection. For example:

-   -   Patient Drug—this section displays the previous n number of        drugs prescribed to the patient by any doctor using the system.        This information can be limited to only those doctors associated        with a given clinic or chain if regulations or doctors        preference dictates so.    -   Doctor's Favourites—this section displays a set of drugs        commonly prescribed by the doctors in question. The list can be        drawn either from a defined list set using the administration        console of the prescribing system, or be dynamically based on        the prescribing history of the doctor in question.    -   Dispensary—this section displays drug that is currently        available in the local dispensary inventory. The prescribing        system performs a real time inventory check to determine which        items should be displayed.    -   All Approved Drug—this section displays a list of all drug        approved for use by the regional authorities (e.g. for use in        USA, Canada, etc.). This list is typically drawn from a standard        drug database commercially available within a given        jurisdiction.

The drug list generally displays the following information:

-   -   Drug Name.    -   Available generic substitutions, with preference given to those        generic drugs currently in the dispensary inventory.    -   The standard SIG (patient instructions e.g. “take one tablet        twice daily”) for the drug, which can be determined by either a        pre-set list or by prescription history, as outlined herein.    -   A graphic indicator or icon used to indicate that a given drug        is currently in stock in the local dispensary. This indicator        can be used across any or all drug categories.

Upon selection of a drug, the system may determine in one aspect of thepresent invention whether there is an appropriate generic substitutionavailable. If so, the doctor is presented with a generic substitutionrequest, containing information about the requested substitution. If thedoctor approves the substitution, the generic equivalent drug isselected in place of the brand-name drug. If the doctor denies thesubstitution, the originally selected drug is entered, and the ‘nosubstitution’ flag is set on that drug for the prescription.

Generally, any number of drugs (or items) can be added to a givenprescription. For each item added to a prescription, a drug interactioncheck may be performed. This is typically completed using informationavailable in the standard drug database from which the list of drugs isdrawn. This check can be made against other drug items included theprescription, drug prescribed to the patient in the past, or evenagainst any known allergies associated with the patient in theprescribing system as determined by the preferences of the doctor usingthe prescribing system. In the case, where no interactions with otherdrug are found, the prescribing flow proceeds as normal. If a potentialinteraction is detected, a visual and/or audible alert is used to informthe doctor. Information on the interaction is provided on-screen, andthe doctor has the opportunity to select another drug, or proceed withthe prescription as is.

The doctor then enters the total quantity to be dispensed (e.g., 30tablets). The doctor can enter any quantity desired, or use a dropdownor other type of list provided in the prescribing application.Generally, the dropdown list will display quantities available in thelocal dispensary at the top of the list. These quantities will bedisplayed with an associated icon or indicator to inform the doctor thatthe quantity is available in the dispensary.

The doctor can enter or select the SIG (patient instructions) for thedrug. When a drug has an associated standard SIG, it will beautomatically populated in the SIG field. This functionality deliversease-of-use for the doctor, and also drives the concept of standarddosage prescribing, which is supported by pharmacists and desirable forthe standardization of drug management. The doctor should have theability to edit or replace the SIG for any given drug at any time.Generally, this capability is provided via free-text editing of the SIGfield.

Standard SIG codes can be determined in a number of ways. Even withinthe same application, different methods of determining standard SIG canbe utilized for different categories of drug (or different lists of druge.g. patient drug, doctor's favorites, dispensary, all approved drug,etc.). For example:

-   -   A drug previously prescribed to a given patient can have its        standard SIG assigned as prescribed in the patient's past        prescription. The SIG could be as prescribed by the doctor        currently using the system, any doctor at the local clinic, or        even any doctor throughout the system, as set in the doctor's        preferences.    -   The standard SIG could alternatively be determined based on a        pre-set setting for the drug associated with either a single        doctor or multiple doctors.    -   In another implementation or other drug category in the same        implementation, the standard SIG for a given drug could be        determined by the prescribing history of the doctor. In this        case, the standard SIG could be re-assigned to match the        previous SIG used for the drug by that doctor, or follow the        prescribing habits of the doctor to match the most commonly        selected SIG for the drug in question.    -   An external database of standard SIG codes could be used as well        (e.g., a list provided with the standard drug database mentioned        above).

In general, when selecting a SIG, a list of common choices should bepresented to the doctor via a dropdown list or other such control.

Certain drugs may require special authorization for one reason oranother. The system should have the capability to facilitate requiredsecondary authorization during the prescribing process.

As an example, the Province of Ontario Canada, under its Ontario DrugBenefits (ODB) Program has designated certain drugs as “limited Use”drugs. These drugs require special authorization from the doctor (basedon the clinical diagnosis for which they are being prescribed) in orderfor the drug to eligible for benefits coverage under the ODB program. Inthis case, the authorization code is drawn from a list of codespre-determined by the Ontario government.

In one particular implementation, the benefits information in thepatient profile designates the patient as a patient under the ODBprogram. Therefore, when a drug is selected, it is compared with thelist of limited use drugs. If it is not on the list, the processcontinues normally. If the drug is on the limited use list, the doctoris presented with a list of possible medical conditions to which alimited use code has been assigned. As each drug could have multiplecodes, the codes are displayed with explanations of each specificcondition for which a code may be assigned to the drug. The doctor canthen select the appropriate code; if no code matches the diagnosis, thedoctor selects “no limited use code”. In this way, the limited use codesfor each drug are added to the prescription entry as required. Uponprinting of the prescription, the limited use codes will be printedalong with the other required drug information. This information canthen be used when submitting a benefits claim to the ODB program.

The doctor can use the prescribing application to enter all requiredprescription information for the drug in question (e.g., the number ofrepeats, special instructions, etc.). When all required information hasbeen assigned to the drug item, the doctor adds it to the prescription.Typically, the process outlined above can be repeated to add multipledrug items to a given prescription.

When all desired items have been added to the prescription, the doctorwill typically print it in a script form that is usable to the patient.The script can take a number of forms, but will typically contain aunique identifier that is associated with the prescription ID numbercreated by the prescribing system. The identifier can be printed as textand/or a bar code, or saved to an RFID tag.

It should be understood that according to a particular aspect of thepresent invention the script will preferably contain a human readabledescription and a machine readable description for use at thedispensary. The human readable description is for use in a traditionalpharmacy. This provides the patient with choice in where they may havethe prescription filled.

The prescription printout will contain all information required by thejurisdiction (e.g., names and addresses of the patient and doctor, dateof prescribing, drug name and form, SIG and special instructions, etc.).In addition, where required, it will be signed by the doctor.

An example of a script is shown in FIG. 2.

Ideally, the script will inform the patient as to where it can befilled. In one implementation, three possible alternatives are providedbased on the drug type and availability: Any Pharmacy, In-clinicDispensary and Home Delivery. This is provided to ensure that thepatient understands their options in filling the prescription.

In certain circumstances, it is possible that not all of the items on agiven prescription can be filled at the local dispensary. In thesecases, the application will typically group the drug items based onavailability in the dispensary, and print those that are available atthe dispensary on a separate printout(s) from those that are notavailable at the local dispensary. Ideally, each of these prescriptionprintouts will be assigned a unique identification number in support ofsolid data management practices.

It is also possible that a prescription with a large number of itemswill not be able to be printed on a single printout. In this case, theitems are typically spread across multiple prescription printouts, eachwith a unique ID number, as above.

Alternatively, the doctor can create an electronic prescription with noassociated scipt. In this case, the patient would access theprescription at the dispensary via an ID number (typically their healthcard or account number) or chit provided by the doctor. The electronicprescription could be digitally signed via digital signature or anyother appropriate means. The prescription information would betransferred and processed throughout the system in the same manner asdescribed for handling printed prescriptions, but without the need forthe physical prescription printout.

Once the prescription has been printed, or submitted in the case of anelectronic prescription, the prescription information is posted to thecentral system. In a typical implementation of the invention, it is alsoposted to the patient's history in the local clinic's clinic managementsystem.

In this manner, the prescription information can be accessed, under theappropriate personal privacy and data security policies, by anydispensary and/or a patient support call centre (not shown). Access toprescriptions from a given doctor or clinic can also be limited to thedispensary or dispensaries local to that clinic, based on legal orregulatory constraints of the region or the preferences of the doctor orclinic.

It should be understood that the present invention contemplates that thesystem shall include, or will be linked to, a call centre provided usingknown technology, in order to support the operations described below,including for example by providing pharmacist on call services and otheraspects of customer care.

The process of dispensing drug via a dispensary to the patient istypically performed in a manner similar to the examples outlined herein.

FIG. 3 illustrates a representative system implementation of the presentinvention. The system includes a central server (44) that includes or islinked to resources that are operable to provide the functionalitydescribed below, including but not limited to quality control, qualitymonitoring, inventory management, distribution management and auditfunctionality. The central server (44) is linked to one or moredatabases (represented as database (50) in FIG. 3. The database (50) andthe central server (44) (and associated utilities) co-operate to storeand to enable the retrieval of various data related to the operation ofthe system components of the invention. Depending on privacy laws andpolicies, regulatory requirements, and other factors, the database (50)may include patient data in certain specific implementations of thepresent invention.

The system also includes a plurality of computers associated with one ormore doctor's offices, and used to access the functions describedherein. These computers are shown in FIG. 3 as computers (42 a) (42 b)(42 c) (42 d). These computers can be any manner of computer deviceincluding a desktop computer, computer terminal, personal digitalassistant (linked to other computer resources or otherwise), laptopcomputer, or tablet computer. Computers (42 a) (42 b) (42 c) (42 d) mayalso be linked to the computer network, thereby providing connectivityto the other system components to enable the functions described below.Computers (42 a) (42 b) (42 c) (42 d) may include or be linked to theresources described below in connection with FIG. 4.

The system also includes one or more dispensaries, as shown in FIG. 3.In FIG. 3, a plurality of dispensaries is shown as (40 a) (40 b) (40 c)(40 d). The dispensaries (40 a) (40 b) (40 c) (40 d), in one particularimplementation thereof, include the resources described below, includingin connection with FIG. 5. The dispensaries (40 a) (40 b) (40 c) (40 d)are also linked to the computer network, thereby providing connectivityto the other system components to enable the functions described below.

The central server (44), via the computer network, is operable to managethe operation of the dispensaries (40 a) (40 b) (40 c) (40 d), includingas described below. In a specific aspect of the present invention, thecentral server (44) is operable to control the operation of thedispensaries (40 a) (40 b) (40 c) (40 d) remotely.

In a particular aspect of the present invention, the central server (44)and the computers (42 a) (42 b) (42 c) (42 d) may be interoperable, viathe computer network, in order to enable provisioning of the computers(42 a) (42 b) (42 c) (42 d), for example, in order to provide access toresources, software updates, data services and otherwise, as webservices provided by the central server (44) to the computers (42 a) (42b) (42 c) (42 d).

The computers (42 a) (42 b) (42 c) (42 d) and the dispensaries (40 a)(40 b) (40 c) (40 d) may be interoperable, via the computer network, toenable a doctor or designate of the doctor to initiate drug dispensinginvolving one or more of the dispensaries (40 a) (40 b) (40 c) (40 d),including as detailed below.

The present invention contemplates different variations in terms of therelationships of medical professionals or their designate and particulardispensaries. Generally speaking, the present invention contemplates thecentral server (44) being operable to define and control which of thedispensaries are associated, from time to time, with computers that arepart of the system or recognized by the system. For example, a singledoctor or her designate and a single corresponding computer (for example(42 a)) may be associated with one or more of the dispensaries (forexample (40 a) or both (40 a) and (40 b)). The doctor or her designatemay be associated with a single dispensary or multiple dispensaries, forexample, if there is more than one dispensary in the doctor's building,or if a particular dispensary (42 a) has a more extensive stock, while(42 b) constitutes a closer dispensary with less stock, it might bedesirable to associate more than one dispensary with computer (40 a). Itis possible that the dispensary could be associated with solely with aparticular doctor's office, depending on volume for example. Typically,however multiple doctors or their designate will be associated with asingle dispensary located close their offices of the doctors inquestion, often in a medical building.

The system may also include an adjudication server (46), optionallylinked to the central server (44) or to the computer network. Theadjudication server (48) may be associated with a third party and notwith the operator of the central server (44). The adjudication server(46) may be operable to engage in a number of transactions related tothe adjudication of insurance claims related to delivery of drugs byoperation of the drug dispensaries (40 a) (40 b) (40 c) (40 d) asdescribed below.

The system may also include a transaction server (48), optionally linkedto the central server (44) or to the computer network. The transactionserver (48) may be associated with a third party and not with theoperator of the central server (44). The transaction server (48) isoperable to generate transactions including payment transactionsenabling patients to purchase drugs (including for example to pay forthe portion of a drug that is not covered by an insurance plan, asdetermined by the adjudication process controlled by the adjudicationserver (46)).

FIG. 4 illustrates representative resources associated with the systemof the present invention, and also certain additional system componentsthat may be part of or linked to the system of the present invention.

The central server (44), in one aspect thereof, includes or is linked toa Drug Distribution Server Application (which may consist of a series ofapplications or an application repository) that provides access to thefunctions described below, including the functionality of the computersassociated with the medical professionals (shown as (42) in FIG. 4) andthe functionality of the dispensaries connected to the system (shown as(40) in FIG. 4). The Drug Distribution Server Application may include orbe linked to a number of different computer programs or additionalcomputer servers associated with such functionality. FIG. 4 illustratesa particular aspect of the Drug Distribution Server Application thatincludes or is linked to an Inventory Management System (58), furtherdescribed below. In addition, the Drug Distribution Server applicationis linked to a Pharmacy Management System (56) for supporting therelated processes described below.

Computer (42) in one aspect thereof, includes or is linked to anAdministration Application and a Prescribing Application. These mayconsist of one or more software utilities in order to provide thefunctionality described below.

Dispensary (40) in one aspect thereof, includes or is linked to aMaintenance Application and a Dispensing Application. These may alsoconsist of one or more software utilities to provide the functionalitydescribed below.

The dispensary (40) may also optionally include or be linked to a VideoConferencing utility for providing video conferencing communicationbetween the dispensary (40) and a remote location in order to provide,for example, video conferencing communication between a patient and apharmacist. In one particular implementation of the present invention,the system also includes a videoconferencing server (52) which is linkedto the Video Conferencing, which elements co-operate to provide saidvideo conferencing functionality.

A schematic diagram depicting elements of a robotic prescriptiondispensary is provided in FIG. 5. This embodiment is a roboticprescription dispensary (in some cases in this disclosure referred to asa “dispensary”). The casing of the dispensary is preferably formed ofsteel having a nylon powder coating with sleek finish. Hardware devicesshould be mounted internally securely. Jacks located on the back providefor LAN, WiFi and power, for example. For the application controlsoftware, by way of example, a Microsoft WINDOWS™ based PC runningcustom designed application and controller software with off-the-shelfdriver software can be used. There is provided a prescription bar codereader that reads standard bar codes from printed prescriptions.According to one implementation, a 4″ wide commercially availabledouble-sided cheque scan can be used. A payment terminal will allow forvarious methods of payment, including debit and credit cards.

For use with the system, all credit cards or debit cards conform to thephysical dimensions as specified by the ISO-1 standard size (85×54×0.8mm). Preferably the processing will be done directly with a bank ratherthan through third party processing. “Track 1” and “Track 2” shall beread from the cards, and the data passed to the local server in amessage bundle for processing, in a manner that is known.

For the debit cards, the keypad needs to be secure. A debit keypad canonly be used in circumstances where the transaction can be monitored bya live person. If any tampering is detected, the dispensary scrubs thetransaction. All Pin data must be in volatile memory. It must never bestored or committed to permanent storage.

Regarding security, there will be sensors within the machine to indicatethat door was opened, and all door open events will be logged. With thelock closed, the circuit is armed. Any disturbance will cause the alarmto trigger. With the lock open the circuit is disarmed, however, ifthere is any tampering with the inside of the delivery area, a warningwill be generated. All warnings and alerts are sent to the server tonotify appropriate staff.

Access to the dispensary may be granted in three separate ways:

-   -   1. An employee card is assigned a magnetic card that is an        encrypted access card. If an employee uses the same employee        card at different clinics while at one clinic then a cloned card        is in use. This type of usage should be detected and the locking        out of both cards would occur.    -   2. A PIN number provides access, using either the touch screen        or keypad.    -   3. A physical key provides access, similar to other        dispensaries.

The employee card and the PIN will release the electronic lock, and thephysical key will release the physical lock. When the door is open withauthorization, the machine enters a maintenance/admin mode which enablesextra functionality that is not otherwise available, e.g.: (i) using theembedded cell-phone to call central office; and (ii) using the displayand keypad for editing machine parameters and/or initiatingcommunications with the central server.

If unauthorized access if detected, a small concealable wireless camerawill begin recording. There should be source of illumination when thedoor is opened sufficient to light up the face of an intruder. Oneoption (for streaming video or photos) is to use a wireless system basedon 802.11, for example, such that the camera is essentially a peripheralof the local server. An 802.11 repeater may be needed. All wirelesscomponents should be limited to known MAC addresses and encryptedtraffic. Another option (for photos only) is to use a camera tied to thecustomer support cell phone (no 802.11 required).

It should be understood that the present invention contemplatesintegration with the Clinic Management Software (CMS) system, asdescribed above. Alternatively, the system of the present invention isoperable to send a message to a CMS system, which is preferably anencrypted electronic message. In response, the system of the presentinvention preferably received an electronic message that includesencrypted patient information require for processing the prescription.

Once the drug inventory hits a predetermined low water mark and/or aperiodic milestone is achieved, a purchase order (“PO”) type message issent from the dispensary to the server. This PO tells the servicedprovider what drugs the dispensary needs. All other pending servicerequests will be scheduled at the same time to ensure that a servicetrip is optimized.

When the lockbox is full or nearly full, the entire lockbox is replacedwith an empty one, and the full one is taken away by the serviceprovider. When the lockbox is opened the prescriptions should be auditedand confirmed that all prescriptions retained by the dispensary matchesthe prescriptions audited.

Regardless of capacity of the rejects bin, rejected drugs should becollected as soon as possible after being detected (and replacementstock put back in the machine).

There should be regular maintenance and top-up of consumables (media &ink) for all printers involved.

A drug delivery hopper is ideally provided at a reasonable height toallow access for most users. Preferably there is a light inside. An RFIDreader can be placed in the hopper determines if a product is not pickedup by a user. A camera also takes a picture of the item, and can beviewed in real-time by the call centre pharmacist. The hopper is alsosubject to a lock, controllable from the PC, and that is tamperresistant and sturdy.

If the RFID read of a bottle does not equal the prescribed drug, thenthe drug goes to a waste bin for collection by servicing. The dispensarysoftware will automatically issue the error to the call centre, and willdecide to lock machine and/or take over session and speak to consumer.

It is generally required that the drug information printer print thedrug information sheet from the adjudication database; and that theprinter itself be sturdy, and notify the PC of ink status, jam and paperout conditions required. The printer is preferably mounted securely, andhas a relatively large paper capacity (e.g., at least 500 sheets).

A 15″ or 17″ touch screen is provided, for example, for the input,allowing a large text size and potential advertising space. A keyboardis also provided with a trackball for further input.

A camera is provided for security and for call centre interaction.Similarly, an internet-protocol phone is provided for call centreinteraction, facilitating the system for blind patients. Alternatively,a speech output device may be implemented for instructing the patientsvia computer generated voice.

An uninterruptible power supply (or “UPS”) provides for a gracefulshutdown in the event of a power failure (once a transaction iscompleted).

A speaker and headset jack will be controlled by the dispensaryapplication software. If the headset is connected then the speaker isoff, and vice versa.

A wireless LAN adapter is preferably provided to connect to the doctor'shandheld and maybe office LAN. Cable connectors on the back of themachine include the power cord for the unit (e.g., need one cord outfrom UPS and internal power bar or UPS multiple plugs). A network cablefemale jack is provided connecting to high speed internet service. Anetwork cable female jack is provided for LAN connection to the doctor'soffice, or handheld etc. Further, a male coaxial cable jack is providedfor an antenna for WiFi transceiver.

The dispensary may incorporate biometrics technology for authenticatingthe identity of a user of the dispensary, as discussed herein.

The patient typically interacts with the dispensary via a standard inputdevice such as a touch screen monitor or keyboard and trackball. For thepurposes of illustration, in the example below, the patient uses a touchscreen monitor to interact with the dispensary. While the graphic userinterface presented below is typical for an implementation of theinvention, it is presented only as one possible implementation.

In one particular implementation, the patient selects from a number ofoptions using a touch screen monitor. The options presented are “NewPharmaTrust Prescription”, “Pick-up Refill” and “New HandwrittenPrescription”. Upon selecting New PharmaTrust Prescription, the patientis prompted to insert the prescription printout that was provided by thedoctor.

The method steps for having a prescription filled are illustrated inFIG. 6.

Once the patient has inserted the prescription printout, both sides ofthe printout are scanned, and the barcode is read to enable thedispensary to identify the prescription in question. Ideally, amechanism for scanning both sides of a printed or handwrittenprescription is implemented for flexibility.

In another implementation, the RFID of the prescription or chit would beread to identify the prescription.

In yet another implementation of the invention, the patient'sidentification number (health card, account number, etc.) would be usedfor identification of the patient and prescription to fill.

Using the prescription ID, the dispensary system validates theprescription, and loads all required information associated with thepatient and prescription.

The system requests confirmation of the patient name. Typically, thepatient is also prompted to accept the dispensary terms of use at thistime. The patient clicks a button on the screen to confirm, or a cancelbutton to terminate the transaction, and retrieve their prescription.

The dispensary then displays a list of the drug to be dispensed.Typically, the patient can deselect any items they do want dispensed atthe present time (e.g. maintenance drug they already have on hand or athome). These items can be saved for later pick up, or delivered at alater time via a home delivery service. The patient presses an on-screenbutton to confirm.

It should be understood that the present invention enables asubstantially automated prescription repeat service that can be offeredthrough home delivery, as an example. This is provided, for example, byintegrating the described system with a system used by a home deliveryservice to process repeat prescriptions of drugs. Repeats can also befilled at the robotic prescription dispensary.

In the same way, the patient confirms their contact information. Ifchanges are required to the mailing or billing address, the patient canmake them using either an integrated or on-screen keyboard. The mailingaddress can be used for any repeats or other items to be sent via a homedelivery service.

In an implementation including adjudication of benefits coverage, thepatient is asked to confirm or enter their drug benefits coverageinformation. Typically, this information is edited in the same manner asaddress information.

In implementations of the invention that include pharmacist consultationor intervention, once all patient information has been confirmed, avideo conference call with a call centre pharmacist (typically an aspectof the services delivered by a service provider who is responsible formanaging patient interactions) is initiated. In addition, the patientgenerally has the option to communicate with a call centre pharmacist atany time. This is initiated by pressing a “Call Pharmacist” buttongenerally provided as a persistent button on the Dispensary userinterface.

By whatever means and at whatever point the video conference isinitiated, it is generally facilitated via standard video conferencingsystems over the Internet, for example, via a secure channel such as aVPN (Virtual Private Network). The dispensary generally has multiplevideo cameras in place to enable the pharmacist to see the patient andthe drug (while it is still within the dispensary) simultaneously. Astandard web cam is used to provide a live on-screen view of thepharmacist for the patient. In one implementation, the pharmacist'simage is displayed on the same screen as the other interactivecomponents of the dispensary user interface. An alternativeimplementation uses separate computer displays for the graphic userinterface and the video conference display. Voice conferencing can beaccomplished via a standard microphone and speaker embedded in thedispensary, or, to support patient privacy, a standard telephone handsetconnected to the dispensary. Voice data is generally transmitted via thesame system as the video conferencing leveraging the same communicationsystem (e.g., Voice Over IP).

The pharmacist is provided with a proprietary software application thatenables them to review all relevant patient and prescription informationand remotely control the dispensary. This control enables the pharmacistto add or edit data (e.g., patient information, SIG, etc.) and authorizeor terminate the dispensing of drug to the patient. The informationpresented to the pharmacist includes:

-   -   All information contained on the prescription.    -   All pedigree information associated with each drug item before        it is dispensed; this information is drawn from the data        associated with the given item's RFID, and is used for        comparison before releasing the drug o the patient (see below).    -   A standard adjudication system, typically a third-party pharmacy        management system linked via API (Application Programming        Interface) or a simple data connection to the system. This        application is used to process drug benefits claims through the        standard systems in use within the jurisdiction.    -   The dispensary control interface that is used to add or edit        information and control the dispensing process.    -   Live video stream of the patient.    -   Live video of the patient bay (inside the dispensary), which is        used for visual inspection of the item to be dispensed before it        is released to the patient.

In transactions where the patient has received handwritten prescriptionor a prescription printed using a system that does not create a uniqueID for use with the dispensary (i.e. a barcode, RFID or otherwisecorresponding to a unique prescription entry in the system), the patientwould select “New Handwritten Prescription” on the dispensary touchscreen to begin the transaction. Similar to the process outlined abovefor PharmaTrust prescriptions, the dispensary would scan both sides ofthe prescription. As the prescription information would not be presentin the system, a video conference call with a call centre pharmacistwould be initiated directly following the prescription scanning process.The call centre pharmacist uses that same systems outlined above, and ispresented with the same information and authorization displays asdescribed for a PharmaTrust prescription, however, they would manuallyenter all patient and prescription information (unless the patientalready exists in the system, is which case they would simply need toadd the prescription information to create a new prescription in thesystem). In this case, the image of the scanned prescription is veryimportant, as it is used by the pharmacist to visually authenticate theprescription as is currently done in pharmacy, but from a remotelocation.

Once the video conference has been initiated, and all requireinformation has been entered, the drug benefits claim is submitted foradjudication using whatever standard system is customary in thejurisdiction. For example, the pharmacist can use a standard pharmacymanagement system to submit the claim based on information manuallyentered into the system or automatically transmitted to the pharmacymanagement system by the system. In one implementation of the invention,this data transmission is accomplished via an API provided by thepharmacy management system software vendor. In other implementation, thetransmission could be facilitated via posting data from the system tothe pharmacy management system at the database level, or any otherappropriate data sharing method. In submitting a benefits claim,pharmacy management systems typically use either private networks orsecure Internet connections to communicate with benefits providers usingmessaging protocols standardized by benefits providers or regulatorybodies. These messaging standards can also be leveraged by thedispensary system for automated submissions with no pharmacistintervention, or pharmacist-assisted submissions without the use of athird-party pharmacy management system.

Once a claim has been submitted, the benefits provider generallyresponds in near real time in a meaningful way according to thejurisdiction's messaging standards. The response will indicate whetherthe payment for drug is covered under the patient's benefits plan, andhow much the co-pay (the amount the patient is required to pay out ofpacket, if any) is. This information is either passed automatically tothe dispensary system, or manually entered into the dispensary controlscreen by the pharmacist.

At this time, the results of the benefits claim are typically displayedto the patient via the dispensary display screen.

If the drug was not covered by the patient's benefits plan or thepatient is required to pay a co-pay, the total payment required (whichwill generally include a professional services fee similar to thedispensing fee charged by pharmacies) is displayed. The patient choosestheir preferred method of payment. Most implementations allow paymentvia debit or credit card, while others include the ability to pay viacash using integrated standard dispensary cash box systems. Credit anddebit card payments are typically facilitated via integrated mag stripereaders, secure PIN pad hardware appropriate for use in unattendeddispensary settings, and software/system connection with credit/debitcard processors. Connection to card processors are typically implementedusing private networks, wireless connections or secure Internetconnections to send and receive processing messages via an API or othersuch interface provided by the card processor.

Upon approval of the payment transaction, the drug is picked, labelledvalidated and presented to the patient along with any required druginformation and/or receipts.

In an implementation of the invention involving a remote roboticprescription dispensary, this process is accomplished without thephysical intervention of the pharmacist or any other administrativestaff. The dispensary is comprised of a certain number of drug shelves,based on the requirements of the clinic in question. Ideally, eachdispensary will be configured to provide the most efficient use of spaceand optimize inventory availability. The inventory management systemdeveloped is designed specifically to provide optimal customization ofslot sizes and drug inventory based on the prescribing history of theclinic in question. In this implementation, the dispensary has a roboticpick head that is used to retrieve the standard dosage drug items fromthe slot in which they are stored. To dispense a given item, the pickhead moves to the appropriate slot, and retrieves the desired itemideally using an apparatus designed to handle items with differingshapes, sizes, weights and forms (e.g., large and small boxes, bottles,etc.). Once the pick head has retrieved the item, it will move the itemto an appropriate location for scanning of the item's RFID tag. Ideally,the RFID scanner would be capable of detecting the presence of multipleRFID tags to ensure that the wrong item is not mistakenly dispensed tothe patient. It is important to note that the system has access to thestocking matrix of the dispensary (i.e. which items are assigned towhich slots), and as such can determine if the correct item has beenselected by comparing the RFID tag scanned with the expectation based onthe stocking matrix.

If the RFID scan fails for whatever reason (e.g., missing or incorrecttag, multiple tags, etc.), the item is moved to the discard bin forlater removal during the normal inventory management and dispensarymaintenance process as described in the appropriate section of thisdocument

A successful RFID match will cause the item to be moved to the labellingstation of the dispensary. This movement is generally performed by astandard or customized X-Y robotic arm or other such mechanism A labelfor the item is printed with all information required by regulations inthe jurisdiction. This information typically includes patient name;doctor name; patient address; drug name and manufacturer; drug quantity,form and formulation; number of repeats; SIG (patient instructions fortaking the drug); clinic contact information; etc. In oneimplementation, the drug label is printed on a 2″×3″ label that includesbranding associated with the clinic and dispensing service. Onceprinted, the label is applied to the drug item in such a way that itcannot be easily removed. This is done to support patient safety byhelping to ensure that the appropriate drug information is available onthe drug package. The label should ideally be applied in a manner thatcan reliably apply the label securely on various package sizes, shapesand materials with appropriate placement on all packages in use (i.e.the label should be securely applied with straight positioning on allitems dispensed via the dispensary).

Once the drug item is labeled, it is generally moved to a patient bay (alocation where it can be retrieved by the patient) via a conveyor beltor other such mechanism. In one implementation involvingpharmacist-assisted remote dispensing, the patient bay includes a camerathat is use to provide the pharmacists a real time video feed of thedrug before it is released to the patient.

Before the item is released to the patient, it undergoes a final set ofvalidation checks to protect patient safety and ensure that the correctitem is being dispensed. In one implementation of the invention allpedigree data associated with the item (during the process of preparingthe item for use in a dispensary) is compared with the attributes of theitem in the patient bay. An RFID scan is performed to ensure that theitem is the item scanned earlier in the process. The item pedigreeattributes are analyzed to ensure that the drug is safe to dispense. Forexample, the expiry date has not passed, there has been nor recall onthe item's bin or lot by the manufacturer, etc. The item's environmentalvariable history is processed to ensure that it has been subjected to nounacceptable excursions in temperature or humidity. This is supported bythe fact that temperature and humidity are continually monitored andlogged in the warehouse as well as the dispensary. By examining theenvironmental variable log for the times in which a given item residedin the warehouse or a particular dispensary, temperature and humidityhistory can be determined for the item and compared with the acceptableranges as set by the pharmaceutical manufacturer. The package history ofthe item is also drawn from the event log of the system, and validatedfor acceptability. This history is comprised of each movement-basedevent to which the item has been subjected. For example, the historycould log the date and time of shipment from the manufacturer, receiptin the warehouse, repackaging and serialization (i.e. application of theitem's RFID tag and entry of its pedigree attribute in the inventorymanagement system), placement in dispensary and dispensing to thepatient (the current date and time). The presence of all of these eventsin the item's history provides a strong indication that the appropriateprocesses were followed, and delivers further evidence in support of thesafety of the drug for dispensing to the patient. A weigh scale is alsopresent in or near the patient bay, and the item weight is compared tothe weight in its associated pedigree data set to make sure that it iswithin an expected tolerance based on the addition of the label, etc.

It should be understood that this set of validation data and checksprovides the necessary assurance prior to releasing the drug to thepatient of the item's identity (i.e. the item in the patient bay is whatit is supposed to be) and suitability for patient use. These checksprovide a much higher standard of patient safety and drug tracking thanis available with existing systems, which track none of the items listedabove in a reliable or auditable manner.

In implementations involving automated dispensaries with no pharmacistinvolvement, the camera in the patient bay is used to take a digitalpicture of the item before it is dispensed. This picture is added to theitem's history, and used for audit and/or tracking purposes.

In implementations in which dispensing is pharmacist assisted, the imageof the item in the patient bay is compared by the pharmacist to theimage of the item taken when it was initially RFID tagged and entered inthe system (i.e. serialized) and stored with its pedigree data. Thisfinal visual inspection, coupled with the checks outlined above,provides an even higher level of safety to the dispensing process. Inthese cases, the pharmacist can choose to discard the item if any of thechecks fail, or the item does not pass their visual inspection.Otherwise, they can approve the dispense, and release the drug to thepatient. At this point a digital image of the item is taken and saved inits history as described above.

In implementations leveraging remote robotic dispensaries, drug istypically released to the patient by opening the external door to thepatient bay. The patient can then retrieve the drug. Sensors (e.g. lightbeam or any other appropriate mechanism) are used to determine whetherthe item is retrieved by the patient. Typically, after a certain amountof time, the patient is prompted on the dispensary graphic interfacedisplay to determine if more time is required to retrieve the item. Ifthe item is not retrieved, the door to the patient bay will close andlock, and the item will be moved to the discard bin. In this case, thefailed dispense is logged, and the call centre is notified and promptedto take appropriate action, and the transaction is terminated. Once thetransaction has been terminated, the dispensary returns to the welcomescreen, and resumes its normal operating behaviour.

If the item is retrieved by the patient, the door to the patient baycloses, and the process is either repeated (starting with picking thenext item from the appropriate shelf) for the next item, or if all itemshave been dispensed, the transaction is completed.

Typically, drug information sheets, payment receipts and Drug PedigreeCertificates are printed for the patient at the time of the transaction.An example of a Drug Pedigree Certificate is provided as FIG. 7.Printing of drug information sheets and Drug Pedigree Certificates isgenerally performed as a parallel process upon the release of each itemto the patient. Payment receipts are typically printed following therelease of the final drug item.

In pharmacist-assisted implementations, once the transaction has beencompleted, the pharmacist terminates the video conference with thepatient.

In situations involving a single doctor or small office, an alternativeimplementation of the invention is possible. Rather than use a roboticdispensary as outlined above, a smaller unit that includes the patientinterface elements of the dispensary (i.e. prescription scanner,display, payment mechanisms, dispensing software, etc.) can be put inplace. In this case, all of the processes outlined above would becarried out in a manner similar to the processes described for a typicaldispensary, with the exception of the processes associated with picking,validating and releasing the drug item. In such an implementation, oncethe payment transaction has been completed, the patient is presentedwith a chit (e.g. a token, RFID tagged card, mag-striped card such asthose used in parking garages, etc.) to be presented to the receptionistor other designated individual. The receptionist would log into adispensing console (ideally a standard computer with any requiredperipherals such as an RFID or barcode scanner, information sheetprinter, etc.), scan the chit, and be presented with information onwhich items are to be dispensed. The drug packages could reside in asecure locked cabinet of an appropriate sort. The receptionist wouldunlock and open the cabinet, and retrieve the required drug items. Eachitem would be RFID scanned into the dispensing console system forvalidation of the pedigree attributes described in the processes above.A weigh scale could also be connected to the console to provide weightcomparison as described above. Upon validation of the item to bedispensed, the receptionist would print the drug information sheets,Drug Pedigree Certificates and receipt, ideally on a standardhigh-quality printer, and give the drug items and printouts to thepatient. In this manner, the cost and space requirements for adispensary can be mitigated to deliver a viable system for small doctoroffices. At the same time, the patient will still receive the safety andtracking benefits offered by the system.

Once an item (or items) is dispensed to a given patient, the patient'smedical file is typically updated on the database, and any repeats onthe prescription are saved in the system. Generally, these repeats aretransferred to whatever pharmacy management system is in use by theservice provider via the same API or data-sharing connections used forbenefits claims.

By updating the patient file, the doctor can be notified that thepatient has filled their prescription. This is information that doctorsdo not receive under the currently prevailing system for fillingprescriptions. In a particular implementation of the invention, thedoctor is also provided a repeat approval function within theprescribing application. This function displays all of the repeats thatwill be required in the near future by patients who elected to filltheir prescriptions at the dispensary (or who have had their repeattransferred to the service provider's pharmacy from another pharmacy).The doctor selects repeats for approval based on the on-going need ofthe patient. In this way, patient safety is supported by more focuseddrug regimens, and doctors remain involved in the on-going supervisionof patient drug between office visits. The healthcare system is alsospared the additional cost of filling prescriptions for which the doctorhas determined there is no further need. Typically, once the doctor hasapproved a given repeat, payment is processed via a pre-authorizedcredit card transaction or other appropriate method, and the drug iseither delivered to the patient by a home delivery service (courier orotherwise) or can be picked-up by the patient at the dispensary.

To pick-up a pre-authorized refill from the dispensary, the patient willtypically press a “Pick-up Repeat” button on the graphic display of thedispensary, and be either immediately connected with a call centrepharmacist (as with handwritten prescriptions described above) or enteran authorization code provided by the service provider. Theauthorization code could be anything from patient account logininformation to a mag-striped patient card issued by the serviceprovider. In any case the authentication method would provide assuranceto the identity of the patient in question. Once the patient has beenidentified, the transaction would take place in much the same manner asfor a new PharmaTrust prescription.

With reference to FIG. 7, a drug distribution method is a further aspectof the present invention. In accordance with this aspect, product isreceived from a manufacturer or supplier and when it arrives at thewarehouse for stockpiling it is compared against orders placed in thesystem. If the product matches that which has been ordered, it is queuedfor inspection by Quality Assurance. A set of Standard OperatingProcedures (SOP) is pre-defined for the handling, preparation (includinghandling and preparation as may be required in conformity with thespecific requirements based on attributes of the dispensary of thepresent invention), tracking, quality control and monitoring (includingrelated audit procedures), and other aspects of distribution of drugs,generally speaking and also specifically based on the present invention.It should be understood that “SOP” or “Standard Operating Procedures” asused in this disclosure has the meaning specified in the foregoingsentence. These procedures provide detailed workflow and end productpackaging instructions, along with details on how to handle anyexception cases that may be encountered. This can be important forquality control purposes. The initial product inspection is carried outas per the appropriate SOP. Rejected product is handled as indicated inthe appropriate SOP. Approved product is resealed in its shippingcontainer, and entered in the warehouse inventory system.

An RFID tag is applied to the shipping container. The RFID tag is thenscanned into the inventory tracking system.

Typically, the inventory tracking system is a custom developed systemdesigned to track items through the various forms and status conditionsthrough which they pass in the processes associated with the invention.This must include states such as bulk inventory items (i.e. items inno-standard dosage packaging) as well as standard dosage items fullyprepared for use in a dispensary. It must also track the differingpossible states and locations for each item such as queued in the pickshelf, assigned to a given dispensary, or at rest in a dispensary. Inaddition, the inventory tracking system must have the capability totrack all required pedigree attributes and data used throughout thesystem. Pedigree attributes are those attributes of an item that impactits suitability for use by patients, but remain largely staticthroughout its life cycle. As an example, the following pedigreeattributes are used within one implementation of the invention:

-   -   Drug Name    -   Drug Manufacturer    -   DIN Number    -   Lot Number    -   Bin Number    -   UPC Code    -   Expiry Date    -   Date of Receipt by the Service Provider    -   Purchase Order Number (PO Number)    -   Item Weight    -   A Digital Picture of the Item taken when it is first        “serialized” (i.e. has the RFID applied, pedigree attributes        logged, and is prepared in standard dosage form)

Another set of data is generally tracked for each item, this data setbeing called “pedigree data”. Pedigree data can be a set of datarepresenting any non-static events that may impact the suitability of astandard dosage item. This data is generally tracked as an event log.Examples of information tracked in this data set are:

-   -   Environmental Variables:        -   Temperature        -   Humidity    -   Transportation Events:        -   Date Received from Manufacturer        -   Date the Item is Serialized        -   Date of Shipping to a Dispensary        -   Date the Item is Dispensed to the Patient, etc.

The nature of this information enables strong tracking of an itemthroughout its life cycle, and provides strong assurance of itssuitability for use by patients.

The container is staged (i.e. place in an appropriate designated area)for unpacking and processing as per the appropriate SOP.

The system is based on the concept of standard dosage dispensing. Inthis type of dispensing, single unit items are referred to as “standarddosage” items or packages. This is to indicate that the items areappropriate for use in the dispensary and for dispensing to patients.The actual number of pills, capsules, etc. contained in a given standarddosage package will vary based on the drug and dosing regimen. Thisregimen is derived from information provided by the drug manufacturer,and the common dosing practices for the drug in question. Bystandardizing the dosing process, patient safety is support through morepredictable drug usage and compliance with manufacturer recommendations.It is possible that a single drug type may have multiple types ofstandard dosage packages (e.g., one-month and three-month supplies).

The multi-unit shipping containers are retrieved for unpacking asrequired based on an inventory queuing report produced via the inventorymanagement system (IMS) to detail which drug product has been receivedand must be prepared in standard dosage packaging.

The RFID of an appropriate container is scanned into the IMS to indicatethe drug to be prepared as well as its various attributes. The containeris then opened, and the single unit items are handled as follows:

-   -   Items that are appropriate for use in a dispensary are prepared        for processing as detailed herein.    -   Items that are not appropriate for use in a dispensary are        queued for repacking into appropriate dosage and form as        detailed herein.

Note that the attributes drawn from the RFID scan will be applied toeach of the standard dosage items drawn from the container.

Once the standard dosage items have been queued for processing, a uniqueRFID tag is placed on each package as per the appropriate SOP. Theattributes of the drug drawn from its parent container are alsoassociated with the standard dosage item in the inventory managementsystem. Pedigree attributes specific to the individual item are thenadded to its profile. These attributes are used for identification andtracking processes throughout the system. Once the items have been addedto the system, they are placed in a pick shelf to be retrieved duringthe dispensary inventory replenishment process.

The pick shelf houses a number of bins that are used to stage items thathave been prepared for use in a robotic prescription dispensary. Eachbin on the pick shelf has a bar code or RFID for easy location andidentification, and contains only a single drug type, form and package.When placing a standard dosage item into the bin, the item's RFID isscanned into the IMS, followed by scanning of the bin's RFID or barcode.If the drug type, form or package does not match that assigned to thebin, the user is notified, and prompted to select a different bin. Ifthe drug type, form and package matches that assigned to the bin, theuser places the item in the bin and repeats the process with theremaining items to be placed in the pick shelf. The IMS maintains anon-going inventory of all items that have been placed in the pick shelf.

When an item must be repacked for use in a dispensary, the containerRFID is scanned into the system to indicate the drug to be prepared aswell as its various attributes. The drug is removed from themanufacturer packaging or selected from bulk packaging (whichever isappropriate), and prepared for repacking as per the appropriate SOP. Thedrug is counted in standard-dosage quantities, and repackaged intodispensary-appropriate packages as per the appropriate SOP. Drug labelsare printed and applied to the standard dosage packing. These labels mayinclude all information (e.g., manufacturer name, drug name,formulation, drug form, quantity, expiration date, lot number, etc.)legally required for prescription drug. This information is determinedvia the product association as indicated by the RFID scan describedabove. The completed standard dosage packages are compared against theItem Masters as per the appropriate SOP.

In one implementation of the invention, dispensary inventory isrestocked by first producing and reviewing a clinic inventory report viathe inventory management system. This report displays the stockingrequirements for any or all dispensaries. Stocking requirements aregenerally based on the prescribing habits of the clinic combined withthe actual historic inventory flow through the dispensary.

The IMS is then used to select a particular dispensary requiringrestocking. A visual representation of the dispensary and thearrangement of its internal drug shelves (along with drug typeassignments for each slot and detail of the current inventory level ofeach slot) is displayed on the IMS computer screen. Using the IMS, arequired item is then selected from the pick shelf, and is RFID scanned.Upon scanning, it is automatically assigned to an appropriate slot inthe dispensary. This process is repeated for each required item. In thisway, each item can be assigned to a particular slot before it isdelivered to the clinic is question when desirable for theimplementation of the invention.

A clinic distribution container is then selected for use. Thesecontainers are used to transport drug items to dispensaries, and willcontain only those items required for a particular dispensary tosimplify the distribution and dispensary loading process. In addition,each container is sealed for security before it is transported to thedispensary in question.

All items assigned to the particular dispensary are placed in thedistribution container. An RFID tag is placed on the container, andscanned into the IMS, which assigns the container to the dispensary inquestion. The distribution container is then staged for pickup bydelivery personnel.

When delivering product to dispensaries residing at clinic locations, aclinic delivery report is produced and reviewed via the IMS. This reportdisplays the details of the deliveries that have bee queued as describedabove. Multiple deliveries may be assigned to a single “run”. Theappropriate delivery container is selected from the staging area. Theuser logs into the delivery management screen (via the IMS). The RFID ofthe distribution container is scanned, and thus checked out for deliveryby the user. The distribution containers are loaded into a deliveryvehicle. The distribution container(s) are then transported to theappropriate clinic(s).

The following is an example of the process of loading a dispensary andremoving items that have been discarded (for various possible reasons)during the operation of the dispensary.

The maintenance technician unlocks and opens the dispensary. Onceopened, the dispensary enters a maintenance mode which enables the useof the internal maintenance application via a computer touch screen thatgenerally resides inside the dispensary. From this touch screen, thetechnician logs into the maintenance application. User authenticationcan be performed via user name and password, RFID scan of the technicianbadge, or in another appropriate manner.

The technician scans the RFID of the distribution package to identifythe items to be stocked using an RFID scanner also in place within thedispensary. The seal of the distribution container is then broken, andthe container is opened.

A standard dosage item is selected from the distribution container, andplaced near the RFID scanner (located inside the dispensary). The item'sRFID is automatically scanned by the maintenance application. Themaintenance application indicates the appropriate slot location for thescanned item within an inventory matrix screen (the same visualrepresentation of the dispensary shelf layout described above), and anLED or other visual indicator lights up in the slot within thedispensary. The indicated slot is that to which the item was assigned inthe processes described above. The technician places the item in theslot indicated. The technician confirms that the item s has been placedby clicking a button in the maintenance application. This process isrepeated for all items assigned to the dispensary in question.

The maintenance technician then views a report of the items to beremoved from the dispensary. This report can be run from the IMS beforethe technician leaves the warehouse, or can be run from the dispensarymaintenance application. The report indicates items that are known tohave been discarded by the dispensary during its operation. All itemsare removed from the discard bin in the dispensary, and the technicianchecks for additional items that may have fallen into other areas of thedispensary. All recovered items are placed into the distributioncontainer that was used to transport items to the dispensary. Thedistribution container is then closed and sealed for return to thewarehouse, and the technician logs out of the maintenance application.The technician closes and locks the dispensary, which returns thedispensary to its normal operating status. The distribution container(s)are loaded into a vehicle and returned to the warehouse.

Once the containers are transported to the warehouse, the returneddistribution container is unloaded from the delivery vehicle. Theinventory management system is used to log the return of thedistribution container via an RFID scan. The seal on the container isbroken, and the container is opened. Each item is inspected by qualitycontrol as per the appropriate SOP. Rejected items are disposed of asper the appropriate SOP. All patient identifying materials are removedfrom each item, and queued for disposal. Items approved for use areprepared for re-entry into normal stock as per the appropriate SOP.These are treated in the same manner as normal incoming stock (describedabove). Inventory is adjusted to reflect the stocking decisions madeduring this stage (i.e. the fate of each item is updated in theinventory system). All patient-identifying materials are disposed of asper the appropriate SOP. All RFID tags used in this process are disposedof.

It should be understood that the data and inventory managementprocesses, detailed event logs and use of tracking mechanisms such asRFID, etc., leveraged throughout the system deliver highly detailedauditing capabilities that can be used to delivery accuracy indispensing and promote patient safety.

Generally, every system event in each element of the system (e.g.,inventory management system, dispensary applications, robotic controls,environmental data, etc.) is logged for audit and/or comparisonpurposes. Feedback from software application as well as hardware systemsare logged centrally, and can be used in the process of safety audits,error identification and handling, system performance tuning,examination of trends, etc.

One significant application of this auditing is demonstrated by theproduction of the Drug Pedigree Certificate (as shown in FIG. 8).

This certificate provides a visual reference supporting the suitabilityof a given standard packaged drug for use by the patient. The data usedto produce this certificate is a combination of the pedigree attributesand pedigree data (described elsewhere is this document). The dataelements are evaluated in manners appropriate to the given element.

For example:

-   -   Evaluate the current validity of certain data elements (e.g.,        ensure the expiry date has not passed).    -   Comparing certain data elements against data provided by        manufacturers (e.g., ensure that no recall has been placed        against the lot or bin number of the drug).    -   Measure certain data logs against manufacturer data (e.g. read        the temperature and humidity log data of the warehouse and        dispensary for the time frames during which a given item resided        in the location, and compare to the acceptable range for the        drug to ensure that the has not been subject to any unacceptable        excursions in environment variables).    -   Compare certain current data elements to those logged at the        time an item was initially serialized (e.g. visually compare the        digital image of the item in the patient bay with the image        taken at the time of serialization to ensure that it is the same        item, or compare the weight of the item at the time of        serialization and dispensing to ensure that it is within a set        tolerance range).

The combination of these analyses and data checks provides a very highlevel of assurance to the suitability of the drug for use by thepatient.

As discussed above, the present invention is a robotic basedprescription dispensing system designed preferably for a physician'sclinic operation. The system dispenses medicine immediately,conveniently, more accurately and at less cost than traditional drugstore based dispensing systems.

Conceptually, the present invention operates as follows: a patient is inthe examination room with their physician. The doctor has reachedhis/her diagnosis and is in the process of writing a prescription usinga computer-implemented device, such as a tablet computer. Theprescription interface may notify the doctor and patient of the drugplan coverage allowing the doctor and patient to make the best decisionfor the drug they need. When the drug is selected, a drug utilizationreview can be conducted to ensure check drug interactions. Theprescription along with drug education material is then printed.

The patient then walks to a system unit in the waiting room and insertsthe prescription. Within minutes, the machine selects the appropriatepre-packaged drug, scans it for verification, and releases it to thepatient. The process is painless when compared with the prospect ofpatients having to travel to fill a prescription. More importantly, thepatient's medical record is updated with the record of the dispensingand the patient now is taking their meds immediately, getting betterfaster. If this is a maintenance drug, the prescription repeat will bedelivered to the patient's door within days before their currentprescription ends, or the patient can pick up refills at the dispensary.This seamless integration with mail order delivery improves the chancesthat patients will continue to take drug as prescribed because therequirement to go to a pharmacy to renew prescription resultsnotoriously in gaps in drug treatments.

Preferably, a service provider attends to all aspects of dispensingoperations. In this regard, the system of the present invention ispreferably designed as a “turn key” operation for primary care clinicssuch that all the physician has to do is write the prescription on theordering tablet. Everything from the installation of the system to itsdaily maintenance, payment collections and accounting, health benefitadjudication, and inventory logistics and replenishment is preferablyoperated by the service provider.

It is known that up to sixty per cent of the prescription market is formaintenance drugs. Be it for high blood pressure, high cholesterol,diabetes, depression, etc., patient drug programs require compliance andadherence to prescribed drugs in order to maintain good health.Typically, when a patient receives a prescription and goes to a drugstore for dispensing, the repeats are captured by the drug store and itis very difficult to redirect the repeats to mail order delivery.However, a system according to the present invention effectivelycaptures and diverts prescription repeats for maintenance drugs to ahome delivery service. In this regard, a service provider will operate ahome delivery pharmacy for two purposes: (i) to repackage bulk drugsinto standard prescription doses for the dispensing system inventory;and (ii) to offer mail order delivery services so that patients will beoffered the convenience of home delivery with the service providerretaining this important revenue stream. The mail-order pharmacy andhome delivery service is significantly less costly than pharmacy-basedoperations and takes advantage of the automation prescription drugs fororder fulfillment.

Further, it is known that an average physician writes approximately10,000 prescriptions per year. This corresponds to enormous revenuegenerated for pharmacies. The present invention is designed to dispensemedicine inside physician clinics or directly to patients' home,delivering a more convenient service to patients while capturing aportion of the revenue stream that would otherwise go to pharmacies.Where appropriate, pharmacies can be given access to some or all aspectsof the system, for example, in order to facilitate the choice of thepatient or other situations where it is desirable for the patient tohave the prescription filled by the pharmacy. Either way, however, thedispensing of drugs by doctors enables redirecting of certain revenue todoctors which in turns relieves pressure on the health care system andenables doctors to take the time required to cover drug related issuessuch as interactions more exhaustively and using better tools than whatis currently possible under the existing system. The doctor is the entrypoint for patients to a drug therapy regime, yet the pharmacies have thetools, information and time to cover important health related aspectsthereof. The medical details of a drug therapy regime are in the currentsystem not fully passed on from doctor to pharmacists, which results inmany cases in a loss of efficacy in the therapeutic effect,inefficiencies, miscommunication, the need for pharmacists to follow up,inconsistent instructions and so on. The present invention enablesdoctors to be given with better tools to manage drug treatmentsresulting in a more seamless healthcare system and better healthcare forpatients.

It is also known that physicians routinely prescribe on average only16-18 drugs for their patients. The present invention is designed toservice a physician's prescribing routine and cover a majority of theirparticular dispensing requirements.

Primary care physicians and related secondary healthcare services areincreasingly organized in medical buildings that are designedspecifically to address the multi-faceted needs of a divergent patientpopulation. However, the most under-invested sector of healthcare forcommunications and information technology (CIT) is the primary carephysician's office. The reason for this is that for the doctor CIT hasnot offered sufficient tangible benefits to make the investmentworthwhile. Furthermore many doctors' offices do not attain the scale oforganization to make a significant CIT investment a priority or justifythe staff required to support CIT operations. This technology investmentcan be leveraged to improve healthcare with the doctor's office as thepoint of contact, e.g. by delivering multimedia information on medicaltreatments, accessing rich content from databases, mining prescriptioninformation based on up to date information regarding drug interactionsetc.

The present invention addresses this in the following ways:

1. The system of the present invention is delivered as a turn keysolution with no up-front investment required by the physician.

2. The system of the present invention offers an incremental revenuestream that provides sufficient incentive for the physician to adopt thetechnologies.

3. The system of the present invention aggregates physician practices tothe scale required to generate appropriate returns on CIT investment.

4. The system of the present invention delivers the organizationalability to make a CIT investment mutually beneficial for the physiciansand the patients.

5. All CIT support functions are operated by a service providereliminating any impact on physician or clinic operations and overhead.

The system of the present invention also addresses accuracy andefficiency issues common with pharmacy-based dispensing. Currently, mostprescriptions are paper-based. This results in up to 10% ofprescriptions requiring the physician to be called by the pharmacybecause of they are not legible. Furthermore, studies have documentedthat adverse events associated with prescription errors, some resultingin patient death. The system of the present invention addresses theseproblems, ensuring more secure and accurate fulfillment ofprescriptions.

It will be appreciated by those skilled in the art that other variationsof the one or more embodiments described herein are possible and may bepractised without departing from the scope of the present invention.

1. A method for dispensing drugs comprising: (a) analyzing a pluralityof attributes of a first drug package at a first time to obtain firstanalysis data; (b) recording the first analysis data; (c) analyzing aplurality of attributes of a second drug package believed to be thefirst drug package at a second time to obtain second analysis data; (d)comparing the first and second analysis data; and (e) authorizingdispensing of the first drug package if the second analysis data isvalidated by the first analysis data.
 2. The method of claim 1, furthercomprising assigning a tracking identifier to the first drug packagecorresponding to the recorded first analysis data, and polling thetracking identifier of the second drug package believed to be the firstdrug package at the second time to ascertain the second analysis data.3. The method of claim 1, further comprising monitoring an event historyof the first drug package between the first time and the second time,recording data related to the event history as third analysis data,comparing the third analysis data to a permitted event history for thedrug package, and authorizing dispensing of the second drug packagebelieved to be the first drug package if the third analysis data isvalidated by the permitted event history.
 4. The method of claim 3, theevent history comprising the first drug package environmental history.5. The method of claim 3, the event history comprising at least one ofthe first drug package movement and location history.
 6. The method ofclaim 1, further comprising dispensing the second drug package believedto be the first drug package.
 7. The method of claim 6, furthercomprising issuing a drug pedigree certificate when the drug isdispensed, the drug pedigree certificate bearing at least a part of thefirst analysis data.
 8. The method of claim 1, the first time beingprior to loading the drug package into an automated dispensary.
 9. Themethod of claim 8, further comprising the plurality of attributes at thefirst time including serialization attributes for display on the firstdrug package.
 10. The method of claim 1, the first time being at loadingof the drug package into an automated dispensary.
 11. The method ofclaim 10, further comprising at least one of weighing and visuallyscanning the first drug package, and recording at least one of the firstpackage weight and visual appearance as the plurality of attributes atthe first time.
 12. The method of claim 1, the method performed at anautomated drug dispensary.
 13. The method of claim 1, at least part ofthe method performed at an automated drug dispensary, and another partof the method performed at a remote location, the automated drugdispensary and the remote location being nodes on a communicationsnetwork.
 14. The method of claim 13, in which the part of the methodperformed at the remote location is performed by intervention of a humanagent.
 15. A system for dispensing drugs comprising: (a) an analysismodule for analyzing a plurality of attributes of a first drug packageat a first time to obtain first analysis data; (b) a recording modulefor recording the first analysis data; (c) an analysis module foranalyzing a plurality of attributes of a second drug package believed tobe the first drug package at a second time to obtain second analysisdata; (d) a first comparison module for comparing the first and secondanalysis data; and (e) an authorization module for authorizingdispensing of the first drug package if the second analysis data isvalidated by the first analysis data.
 16. The apparatus of claim 15,further comprising a tracking module for assigning a tracking identifierto the first drug package corresponding to the recorded first analysisdata, and a polling module for polling the tracking identifier of thesecond drug package believed to be the first drug package at the secondtime to ascertain the second analysis data.
 17. The apparatus of claim15, the analysis module for analyzing the plurality of attributes of thefirst drug being the same module as the analysis module for analyzingthe plurality of attributes of the second drug package.
 18. Theapparatus of claim 15, further comprising a monitoring module formonitoring an event history of the first drug package between the firsttime and the second time, a recording module for recording data relatedto the event history as third analysis data, a second comparison modulefor comparing the third analysis data to a permitted event history forthe drug package, and an authorizing module for authorizing dispensingof the second drug package believed to be the first drug package if thethird analysis data is validated by the permitted event history.
 19. Theapparatus of claim 15, further comprising a dispensing module fordispensing the drug.
 20. The apparatus of claim 19, further comprising acertificate issuing module for issuing a drug pedigree certificate whenthe drug is dispensed bearing at least a part of the first analysisdata.
 21. The apparatus of claim 15, the analysis module for analyzingthe plurality of attributes of the first drug package operable toanalyze the plurality of attributes of the first drug package prior tothe first drug package being loaded into an automated dispensary. 22.The apparatus of claim 15, the analysis module operable to analyze theplurality of attributes of the first drug package to identifyserialization attributes for display on the first drug package.
 23. Theapparatus of claim 15, the analysis module for analyzing the pluralityof attributes of the first drug package operable to obtain the firstanalysis data at the first time being at loading of the drug packageinto an automated dispensary.
 24. The apparatus of claim 15, furthercomprising a physical property monitoring module operable to effect atleast one of weighing and recording visual appearance of the first drugpackage at the first time.
 25. The apparatus of claim 15 embodied as anautomated drug dispensary.
 26. The apparatus of claim 15 embodied atleast in part as an automated drug dispensary and embodied at least inpart as at least one of memory, processing and computer programs at aremote location, the automated drug dispensary and the remote locationbeing nodes on a communications network.
 27. The apparatus of claim 26,and further including data input means and data access means at theremote location for data access and input by a human agent located atthe remote location.